study designed to evaluate the safety of prophylactic depakote er in the treatment of adolescents with migraine

Conditions: Migraine

Summary: the purpose of this study is to determine if long-term treatment, up to 1 year, with depakote er is safe in the reduction of occurrence of migraine headaches in adolescents.


Eligibility criteria:
inclusion criteria: * subject and subject's legal representative have voluntarily signed and dated an irb-approved informed assent form and an irb-approved informed consent form, respectively, before any study-specific procedures or tests are performed; * subject is male, or a non-pregnant, non-lactating female; * subject is between 12 and 17 years of age, inclusive, at the screening visit; * subject weighs at least 77 lbs. (i.e., 35 kg); * subject currently has diagnosis of migraine headaches consistent with international headache society (ihs) criteria; * subject is judged to be in generally good health based on the results of a medical history, physical examination, 12-lead electrocardiogram (ecg), and laboratory profile; and * in the investigator's opinion, the subject will benefit from depakote er for migraine prophylaxis. exclusion criteria: * history of allergic reaction or significant sensitivity to valproate or similar drugs; * history of noncompliance with medication or medical instructions; * recent (previous 6 months) history of drug and/or alcohol abuse or has a positive urine drug screen, at the screening visit, for drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and phencyclidine \[pcp\]); * female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives) as judged by the investigator. * use of the following medication classes or any specific drug listed below: * anti-depressants, other antiepileptic drugs (aeds) * aspirin and/or aspirin-containing products * chronic use of systemic corticosteroids, clonazepam,diazepam, erythromycin, ethosuximide, pemoline, phenobarbital,rifampin,tolbutamide, zidovudine * anticoagulant drug therapy; * any serious medical or psychiatric disorder(s), including epilepsy and obesity, that may confound the interpretation of the results from this study; * central nervous system (cns) neoplasm, cns infection, demyelinating disease, degenerative neurological disease, or any progressive cns disease; * history of encephalopathy, hepatitis, pancreatitis, or urea-cycle disorder or any underlying condition/disease, which might interfere with study drug absorption or completion of study drug therapy evaluation throughout the duration of the trial; * screening laboratory results indicate the presence of hepatitis b surface antigen (hbsag), or hepatitis c antibody or known history of any positive test result for hiv; * screening laboratory results indicate: 1. platelet count =/\< 100,000/ul 2. alt or ast =/\> 2 times upper limit of normal (uln); * receipt of an investigational drug within 30 days prior to study drug administration or scheduled to receive any other investigational drug anytime during the study; * participation in a prior depakote er migraine study (m02-488 or m02-554); or if for any reason, subject is considered by the investigator to be an unsuitable candidate to receive depakote or to participate in this study.

Keywords: migraine depakote er divalproex sodium